Bennouna Jaafar, Falchero Lionel, Schott Roland, Bonnetain Franck, Coudert Mathieu, Ben Hadj Yahia Béchir, Chouaid Christos
Oncologie thoracique, CHU Nantes, Nantes, France.
Oncology. 2018;94(1):55-64. doi: 10.1159/000480702. Epub 2017 Oct 25.
The aim of this study was to describe the characteristics of patients receiving bevacizumab plus first-line metastatic chemotherapy for non-squamous advanced non-small cell lung cancer (aNSCLC), with or without brain metastases, in routine clinical practice. Other objectives were to describe treatment efficacy, modalities of use, and safety.
For this non-interventional, prospective, national, multicentre study, data were collected every 3 months over 18 months.
Of the 407 patients analysed, 84 (21%) with brain metastases at bevacizumab initiation had poorer general health than patients with no brain metastases (Eastern Cooperative Oncology Group [ECOG] performance status score = 2: 16 vs. 11%). All but 2 patients received bevacizumab (7.5 or 15 mg/kg/3 weeks in 99% of patients) in combination with doublet chemotherapy. Median progression-free survival and overall survival did not differ significantly between patients with or without brain metastases (6.5 months, 95% CI 5.7-8.1 vs. 6.9 months, 95% CI 5.9-7.6, p = 0.57; 14.5 months, 95% CI 10.0 vs. 12.5 months, 95% CI 10.1-14.7, p = 0.33). In 30 and 32% of the patients, respectively, at least one serious adverse event was reported, with a causal relationship to bevacizumab in 20 and 21% of the patients.
This study confirmed in a real-life setting the safety profile and survival benefits of first-line chemotherapy with bevacizumab in aNSCLC patients with brain metastases.
本研究旨在描述在常规临床实践中接受贝伐单抗联合一线转移性化疗治疗非鳞状晚期非小细胞肺癌(aNSCLC)的患者特征,无论有无脑转移。其他目的是描述治疗疗效、使用方式和安全性。
对于这项非干预性、前瞻性、全国性、多中心研究,在18个月内每3个月收集一次数据。
在分析的407例患者中,贝伐单抗开始治疗时伴有脑转移的84例(21%)患者的总体健康状况比无脑转移患者差(东部肿瘤协作组[ECOG]体能状态评分=2:16%对11%)。除2例患者外,所有患者均接受贝伐单抗(99%的患者为7.5或15mg/kg/3周)联合双联化疗。有无脑转移患者的中位无进展生存期和总生存期无显著差异(6.5个月,95%CI 5.7 - 8.1对6.9个月,95%CI 5.9 - 7.6,p = 0.57;14.5个月,95%CI 10.0对12.5个月,95%CI 10.1 - 14.7,p = 0.33)。分别有30%和32%的患者报告至少发生一次严重不良事件,其中20%和21%的患者的严重不良事件与贝伐单抗有因果关系。
本研究在现实环境中证实了一线化疗联合贝伐单抗治疗有脑转移的aNSCLC患者的安全性和生存获益。